CR 18-024 Rule Text

Related statute or rule: s. 961.16, Stats.

Summary of, and comparison with, existing or proposed federal regulation:

On September 29, 2017, the Department of Justice, Drug Enforcement Administration published its final rule in the Federal Register removing naldemedine from the federal Controlled Substances Act.

Plain language analysis:

The Controlled Substances Board did not receive an objection to excluding naldemedine as a controlled substance under ch. 961, Stats. based upon the federal scheduling. The Controlled Substances Board took affirmative action on November 10, 2017 to similarly treat naldemedine under chapter 961 effective November 20, 2017 to allow for publication in the Administrative Register. The Affirmative Action Order will expire upon promulgation of a final rule.

This rule amends s. 961.16 (2) (a) (intro.), Stats. which excludes naldemedine from the controlled substance schedules.

Comparison with rules in adjacent states:

Illinois: Illinois has not excluded naldemedine from scheduling.

Iowa: Iowa has not excluded naldemedine from scheduling.

Michigan: Michigan has not excluded naldemedine from scheduling.

Minnesota: Minnesota has not excluded naldemedine from scheduling.

Summary of factual data and analytical methodologies:

The methodology was to exclude naldemedine from scheduling to conform with the federal Controlled Substances Act.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:

This rule schedules a drug and does not have an effect on small business.

Fiscal Estimate and Economic Impact Analysis:

The Fiscal Estimate and Economic Impact Analysis is attached.

Effect on small business:

These proposed rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats. The Department’s Regulatory Review Coordinator may be contacted by email at [e-mail], or by calling [phone].

Agency contact person:

Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone [phone]; email at [e-mail].

Place where comments are to be submitted and deadline for submission:

Comments may be submitted to Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, WI 53708-8366, or by email to [e-mail]. Comments must be received by May 9, 2018 to be included in the record of rule-making proceedings.

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TEXT OF RULE

Section 1. CSB 2.58 is created to read:

CSB 2.58 Exclusion of naldemedine. Section 961.16 (2) (a) (intro), Stats., is amended to read:

961.16 (2 )(a) (intro) Opium and substances derived from opium, and any salt, compound, derivative or preparation of opium or substances derived from opium. Apomorphine, dextrorphan, nalbuphine, butorphanol, naldemedine, nalmefene, naloxegol, naloxone and naltrexone and their respective salts and the isoquinoline alkaloids of opium and their respective salts are excluded from this paragraph. The following substances, and any of their salts, isomers and salts of isomers that are theoretically possible within the specific chemical designation, are included in this paragraph:

Section 2. EFFECTIVE DATE. The rules adopted in this order shall take effect on the first day of the month following publication in the Wisconsin Administrative Register, pursuant to s. 227.22 (2) (intro.), Stats.

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